The nutrition and medicine administration found problems at the Indian factory that creates common drugs for American patients, including one medicine that was produced there, and has been associated with at least eight deaths, the federal records show.
The agency inspected the factory after the PROPBLICA investigation in December, found that the plant managed by Glenmark Pharmaceuticals is responsible for an An A negative share of the pill recalls This was not properly dissolved and can harm people. Among the number of recalls, the FDA determined that last year more than 50 million potassium potassium capsules potentially had the opportunity to kill patients from us.
However, revealed Propublica, the FDA did not send inspectors to the factory in Madhja Pradesh, India, because of the Covid-19 pandemic.
When the FDA inspectors went to the Glenmark factory last month – five years after the pre -checking agency – they found problems with cleaning and testing, which, according to them, could affect the medicines sent by US consumers.
In A report in which details of their conclusionsInspectors wrote that Glenmark could not decide why some medicines were not properly dissolved and they caused concern about the plant’s production processes.
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“The equipment and utensils are not cleaned with the appropriate gaps to prevent pollution, which will change the safety, identity, strength, quality and purity of addiction,” the inspectors write.
The FDA edited large inspections of the inspection report that it is impossible to tell whether the inspectors found the reason so that the pills do not dissolve properly, or what drugs sitting in US cabinets potentially at risk of pollution.
Propublica received a report through the Law on Freedom of Information. To justify the censorship of the document, the FDA prosecutor cited commercial secrets “and/or commercial or financial information received from the government, and it is privileged or confidential.”
Health and Human Services Secretary Robert F. Kennedy -Jr., who swore the day before the inspection ended, promised to bring “radical transparency” to his agency controlled by the FDA. Propublica asked at HHS Media Team whether Kennedy considers a significant version of the check, corresponds to his promises transparency and whether he considers the names of drugs that inspectors caused commercial secrets. The media did not answer.
The FDA Socialist press will not say why the agency has waited for so long to check this factory or what, if anything, federal regulators will require Glenmark to fix the problems. “The FDA usually cannot discuss potential and constant issues of fulfillment, except the company,” she wrote.
FDA review at the Glenmark plant, she noted: “was the reason for the check that could be caused if the agency has reason to believe that the object has quality problems to monitor complaints or other reasons.”
Drugs that are not missed properly dissolved can cause dangerous changes in dosage. From the glemarka Memory of potassium chloride in MayThe company told the federal regulator that received reports on eight deaths in the US who took the withdrawn capsules to show FDA Records. Companies are obliged to submit reports on the unfavorable phenomena they receive from patients or their doctors so that the agency can monitor the security of drugs. However, the FDA shares several parts; As a result, the propublica could not independently check what happened in each of these cases. In general, the FDA states that these reports reflect the opinions of people who reported harm and do not prove that it is caused by drugs.
Last year, the 91-year-old woman Maine sued Glenmark in a Federal Court in Newark, New Jersey, which claimed that in June recalled that the company was reminded of potassium chloride. The company denied liability in court statements.
Glenmark press -secretary, which was founded in Mumbai, refused to answer detailed inspection questions, citing current lawsuits. “Glenmark still strives to work hard with the FDA to ensure production operations and quality systems,” the secretary -secretary wrote.
Last month, the head director Glenmark told investors and earnings analysts that 25% to 30% of his income in the US comes from drugs made at the Madhya Pradesh plant.
Inspectors visited the factory from February 3 to February 14. Like all such reports, this notes that the inspectors’ observations “do not present the final determination of the agency” on compliance with the FDA drug production rules.
Inspectors found that Glenmark lacked the proper cleaning procedure that interferes with the remnants of one medicine. While GlenMark rejected three parties when the tests discovered cross -pollution, the inspectors said the same equipment was used to make other drugs that were sent to the United States, their report continued to list the “affected parties”, but it is unclear what these medicines were censored.
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Received propublica
PROPUBLICA asked at the FDA whether any of these drugs are being carried out by the agency. Press -secretary will not tell and instead Sent a reporter to web fda This shows past test results, but does not include Glenmark products because recall.
The main production equipment is not decontaminated before the company uses it to make some narcotics, said Glenmark Vice -President, which is engaged in quality. It is unclear what the drug is because the FDA censored this part of the report.
Inspectors noted that Glenmark received two consumer complaints about side effects to one of his drugs. When Glenmark investigated complaints, the company failed to evaluate the potential problems that may occur when pharmaceutical products are produced using common facilities and equipment, the message said. But the drug name and the type of potential pollution experienced by the inspectors were not clear from the FDA editorial offices.
Glenmark also did not get below why some medicines made at the factory did not dissolve properly, FDA inspectors found. Studies of the company on some parts of faulty medicine did not reveal specific root reasons, and those that made the exact reason were not properly supported by evidence and did not explain all the data, the inspectors write.
Inspectors also expressed concern that some medicines made at the factory and the key ingredients that are included in them “are regularly released by testing for analytical test methods that were not properly verified or verified.” Inspectors listed those who are now in the US market but the FDA edited drug names.
When Glenmark analysts have found problems with medicines, the company sometimes announced these results invalid and “repeated new samples to get the results,” the FDA said. “The parties were ultimately released on the American market.”
Glenmark has been the subject of control over the FDA for many years. Since 2019, the agency inspectors have found large shortcomings at three other companies that have made drugs for US patients. Problems at a single factory were so bad
In October 2023, the recalls arising from the products made at the Madzhi -Prades factory in Central India. Over the next 12 months, which one -off plant was more than 30% of all FDAs, which resemble pills that are not dissolved properly and could harm patients, revealed propublica analysis.
The federal government often does not facilitate consumers to know where their medicines are made. To determine this picture, Propublica had to comply with drug marking from the US National Medical Library with details in two FDA data bases.
Most drugs producing drugs for US patients are in foreign countries, but the Congress investigation has repeatedly found that there are too few inspectors in the FDA to watch them properly.
